FDA-TRACK: Animal Drug User Fee Act Review Goals Summary

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Animal Drug Applications and Supplements

Other Performance Goals

• • Current Performance
• • Historical Performance
• • Goals Summary

• • INAD H Submissions Submitted at Division Level
• • Favorable Outcomes for INAD Protocols and Data Submissions
• • Mutual Recognition Agreements

Relevant Links:

1. • ADUFA V Performance Goals and Procedures
2. • ADUFA Performance Reports
3. • ADUFA Report Information
4. • ADUFA Meetings
5. • FDA-TRACK: CVM Dashboards

On September 30, 2023, the fourth reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA V, was signed into law. ADUFA V amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2024 through FY 2028). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provides FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.

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